SERDOLECT 12 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Serdolect 12 mg film-coated tablets

Sertindol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Serdolect and what is it used for
2. What you need to know before you take Serdolect
3. How to take Serdolect
4. Possible side effects
5. Storage of Serdolect
6. Contents of the pack and other information

1. What is Serdolect and what is it used for

Serdolect contains the active substance sertindol and belongs to a group of medicines called antipsychotics. These work on the nerve pathways in specific areas of the brain and help to correct certain chemical imbalances in the brain that cause your symptoms.

Serdolect is indicated for the treatment of schizophrenia in cases where another medicine is not effective.

2. What you need to know before you take Serdolect

Do not take Serdolect:

If you are or have:

allergy to sertindol or any of the other ingredients of this medicine (listed in section 6)

untreated low levels of potassium or magnesium in the blood

significant heart or circulatory disease

• a severe heart disease, such as:

heart failure with swelling of tissues caused by excess fluid

enlargement of the heart

irregular or slow heartbeats

been born with or had an episode of prolonged ventricular cardiac activity, measured on an ECG, or someone in your family has this abnormal heart rhythm

severely reduced liver function

taking medicines that prolong the time of ventricular cardiac activity or affect liver function. See the first two points in the section "Other medicines and Serdolect" in section 2

Warnings and precautions

Consult your doctor before starting to take Serdolect if you are or have:

• vomiting or diarrhea during treatment with Serdolect
• reduced liver function
• Parkinson's disease
• diabetes or risk factors for developing diabetes
• stroke risk factors, such as high blood pressure, previous stroke or heart attack, diabetes, high cholesterol, dementia, smoker
• over 65 years of age
• history of blood clots or family history of blood clots in the veins, as medicines for the treatment of schizophrenia have been associated with the formation of blood clots.
• seizures
• unusual movement of the mouth and tongue, which can be early signs of a nervous system disorder called tardive dyskinesia
• high fever, rare muscle stiffness, and changes in consciousness, especially if they occur with sweating and rapid heartbeats. These can be signs of a rare but serious condition called neuroleptic malignant syndrome

At the start of treatment with Serdolect, you may feel dizzy when you get up from bed or stand up. Your doctor may reduce this risk by starting with a low dose and gradually increasing it over several weeks. This feeling will usually disappear when you have been taking Serdolect for a while.

Monitoring before and during treatment

Before and during your treatment with Serdolect, your doctor may perform certain tests, such as:

• an electrocardiogram of your ventricular heart activity to check for prolongation of the QT interval

This test is repeated after 3 weeks of treatment or when you reach a daily dose of 16 mg of sertindol. During maintenance treatment, it is performed every 3 months. Additionally, an ECG is performed before and after increasing the dose. This is also done if the dose of another medicine you are taking that may affect the level of sertindol in the blood is changed.

• a test of potassium and magnesium levels in the blood

If potassium or magnesium levels decrease, your doctor will start treatment to correct it. Do not take Serdolect if you have untreated low levels of potassium or magnesium in the blood.

Contact your doctor if you have vomiting, diarrhea, electrolyte disorders, or take medicines to increase urine production. Your doctor may measure the amount of potassium in your blood.

• blood pressure monitoring

Children under 18 years

Serdolect should not be used in this age group as there are no available data.

Taking Serdolect with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Serdolect should not be usedwhen the following medicines are used:

• medicines that can affect heart rhythm, such as:

• certain medicines used to treat irregular heartbeats, such as quinidine, amiodarone, sotalol, dofetilide
• certain medicines used to treat mental disorders, such as thioridazine
• certain medicines used to treat bacterial infections, with active ingredient names ending in "micin", such as erythromycin
• certain medicines used to treat allergies, such as terfenadine, astemizole
• certain medicines used to treat bacterial infections, with active ingredient names ending in "oxacin", such as gatifloxacin, moxifloxacin

• cisapride: a medicine used to treat stomach or intestine problems
• lithium: a medicine used to treat depression and mental disorders

• medicines that affect liver function, such as:
• oral medicines used to treat fungal infections, such as ketoconazole, itraconazole
• certain medicines used to treat bacterial infections, with active ingredient names ending in "micin", such as erythromycin, clarithromycin
• medicines used to treat HIV infections, with active ingredient names ending in "navir", such as indinavir
• certain medicines used to treat high blood pressure and heart disorders, called calcium channel blockers, such as diltiazem, verapamil
• cimetidine: a medicine used to reduce stomach acidity

Other medicines that may affect or be affected by Serdolect are:

• medicines used to treat Parkinson's disease, called dopaminergic agonists
• certain medicines used to treat depression and anxiety disorders, such as fluoxetine, paroxetine
• rifampicin: a medicine used to treat tuberculosis or other infections
• carbamazepine, phenytoin, phenobarbital: medicines used to treat epilepsy
• medicines used to increase urine production, which decrease potassium levels in the blood

Taking Serdolect with food and drinks

Avoid alcoholduring treatment with Serdolect, although it is not expected to have any influence from alcohol.

Pregnancy, breastfeeding, and fertility

• Pregnancy

Serdolect is not recommendedduring pregnancy.

The following symptoms may appear in newborns of mothers who have taken Serdolect during the last trimester (the last three months of pregnancy):

• tremors
• muscle stiffness and/or weakness

• sleepiness, restlessness
• breathing problems
• feeding difficulties.

Contact your doctor if your baby has any of these symptoms.

• Breastfeeding

Serdolect should not be usedduring breastfeeding, unless your doctor says it is absolutely necessary. You should consider stopping breastfeeding if treatment is necessary, as Serdolect is excreted in breast milk.

• Fertility

Serdolect may have adverse effects that can affect your sexual activity and fertility. These are reversible. Please talk to your doctor about any problems related to your sexual activity.

Driving and using machines

Do not drive or use machinery until you know how Serdolect affects you, although it does not cause sleepiness.

Serdolect contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Serdolect contains sodium

This medicine contains less than 1 mmol sodium (23mg) per tablet; this is essentially "sodium-free".

3. How to take Serdolect

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

• initial dose: 1 tablet of 4 mg of Serdolect once a day. Every 4 to 5 days, the dose will be increased by 1 tablet of 4 mg of Serdolect, until the maintenance dose is reached.

• maintenance dose: 1 tablet of 12 mg of Serdolect to 1 tablet of 20 mg of Serdolect once a day.

• maximum dose: 2 tablets of 12 mg of Serdolect once a day, will be considered only in exceptional cases.

Alternatively, the maximum dose can be reached by taking 1 tablet of 20 mg of Serdolect plus 1 tablet of 4 mg of Serdolect.

Patient over 65 years

Your doctor will probably increase the dose of Serdolect over a longer period of time than usual. Your doctor may also prescribe a lower maintenance dose than normally recommended.

Patient with reduced liver function

Your doctor may monitor you more closely and increase your dose over a long period if you have mildly or moderately reduced liver function. Your doctor may also prescribe a lower maintenance dose than normally recommended.

Serdolect should not be used in patients with severely reduced liver function.

Patient with reduced kidney function

Serdolect can be administered to patients with reduced kidney function at the usual doses.

Administration

Take the tablets whole, with a glass of water, every day at the same time. The tablets can be taken with or without food.

Duration of treatment

Take the tablets for the time recommended by your doctor.

Never change the dose of the medicine without consulting your doctor first.

If you want to stop using the medicine, please note the information in section 3 "If you stop taking Serdolect".

If you take more Serdolect than you should

If this happens, contact your doctor or the nearest hospital immediately. Do this even if you do not feel unwell.

The symptoms of overdose are:

• increased fatigue.
• difficulty speaking.
• increased pulse.
• low blood pressure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested. Do this even if you do not observe discomfort or signs of poisoning. Take the Serdolect packaging with you if you go to the doctor or hospital.

If you forget to take Serdolect

Do not take a double dose to make up for forgotten doses.

If you forget to take your daily dose, contact your doctor. Your doctor will tell you how to continue your treatment correctly.

If you stop taking Serdolect

Do not stop taking Serdolect without your doctor's permission, even if you start to feel better. The underlying disease may persist for a long time. If you stop your treatment too early, the symptoms of your disease may return, and involuntary movements may also appear.

Your doctor will advise you on how and when to stop your treatment to avoid unpleasant symptoms that may occur. If Serdolect is stopped abruptly, it may cause withdrawal symptoms such as:

• nausea, vomiting
• sweating
• difficulty sleeping

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor or hospital immediately if you have any of the side effects mentioned in the following 4 points:

Uncommon: may affect up to 1 in 100 people

• very rapid, irregular, or strong heartbeats, dizziness, fainting, difficulty breathing, or chest pain

These symptoms may indicate life-threatening irregular heartbeats.

• uncontrolled movements mainly of the mouth, tongue, and limbs

This could indicate a nervous system disorder called tardive dyskinesia

Rare: may affect up to 1 in 1,000 people

• a combination of fever, rapid breathing, sweating, muscle stiffness, sleepiness, or lethargy

These symptoms may indicate a life-threatening nervous system disorder called neuroleptic malignant syndrome.

Unknown: frequency cannot be estimated from the available data

• blood clots in the veins, particularly in the legs (symptoms include swelling, pain, and redness in the leg), which can move through the blood vessels to the lungs, causing chest pain and breathing difficulties

Other possible side effects that may occur with the following frequencies are:

Very common: may affect more than 1 in 10 people

• inflammation in the nose that causes sneezing, itching, nasal discharge, and stuffy nose
• ejaculation failure

Common: may affect up to 1 in 10 people

• dizziness or sudden dizziness, resulting from a drop in blood pressure when standing up
• dry mouth
• weight gain
• breathing difficulties
• swelling of hands or feet
• a peculiar sensation of pins and needles in the skin
• decreased ejaculatory volume
• impotence
• changes in the electrical activity of the heart (called "prolongation of the QT interval"). Prolongation of the QT interval can lead to symptoms such as palpitations and fainting
• white and red blood cells in urine

Uncommon: may affect up to 1 in 100 people:

• increased blood sugar
• irregular heartbeat, known as Torsade de Pointes
• increased levels of a hormone called prolactin in the blood
• spontaneous milk secretion from the breasts
• seizures, fainting

In elderly patients with dementia, a small increase in the number of deaths has been reported in patients who took antipsychotics, compared to those who did not take them.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http;//www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Serdolect

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Store in the original package, to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Serdolect

The active ingredient is sertindol.

Each film-coated tablet contains 12 mg of sertindol.

The other ingredients are:

• corn starch
• lactose monohydrate
• hydroxypropylcellulose
• hypromellose
• microcrystalline cellulose
• sodium croscarmellose
• magnesium stearate
• macrogol 400
• titanium dioxide
• yellow iron oxide (E172)
• red iron oxide (E172)

Appearance and Packaging of the Product

Serdolect 12 mg is presented in the form of film-coated tablets.

The tablets are beige, oval, rounded on the upper and lower surfaces, marked with the initials "S12" on one side.

Serdolect 12 mg is presented in packs of 7, 10, 14, or 28 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

• Lundbeck A/S

Ottilliavej, 9

2500 Valby

Denmark

Tel: + 45 3630 1311

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Local Representative:Lundbeck España, S.A.

Av. Diagonal, 605

08028 Barcelona

(Spain)

This medication is authorized in the following EU/EEA member states with the following names:

This leaflet was approved in April 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/